Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
Moderate and/or Severe Exacerbation, Eosinophilic phenotype, Elevated blood eosinophil counts, Type 2 inflammation, dupilumab
Brief summary
This study is researching a drug called dupilumab, referred to as "study drug". The study is focused on people diagnosed with COPD to determine if the study drug, in addition to standard of care treatment for COPD, might reduce the reoccurrence of a COPD exacerbation (a "flare-up") happening within the study treatment duration (around 90 days). The study is looking at another research question: • What side effects may happen from taking the study drug
Interventions
DRUGdupilumab
Administered per the protocol
DRUGPlacebo
Administered per the protocol
Sponsors
Regeneron Pharmaceuticals
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Has a clinical diagnosis of COPD prior to randomization, as defined in the protocol 2. Hospitalized or admitted to the ED \>24 hours (from time of first admission or presentation to the ED) for acute exacerbation of COPD as primary diagnosis according to the principal investigator and exacerbation is managed by Systemic Corticosteroids (SCS) ± antibiotics and other appropriate treatments as per SOC 3. Elevated blood eosinophil counts during the current exacerbation, as defined in the protocol. The exacerbation event starts from the day Systemic Corticosteroids (SCS) ± antibiotics are administered continuously up to the day they presented to ED/hospital Key
Exclusion criteria
1. Clinical evidence of pneumonia as the primary cause of admission in the investigator's opinion or acquired during hospital stay 2. Complicating pulmonary conditions during the 8 weeks prior to randomization which may confound treatment assessments, as defined in the protocol 3. Clinically significant pulmonary diseases other than COPD which may impair lung function and interfere with treatment assessments 4. Participants with clinically significant α-1 anti-trypsin deficiency which may impair lung function and interfere with treatment assessments 5. Cardiac-related comorbidity, as defined in the protocol 6. Treatment with invasive mechanical ventilation in-hospital during the index event, as defined in the protocol 7. Any biologic therapy or biologic Investigational Medicinal Product (IMP) to treat type 2 inflammatory diseases within 6 months prior to the screening visit or 5 half-lives, whichever is longer, as defined in the protocol NOTE: Other Protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first all-cause event | Through day 90 | All-cause event may include non-elective hospital readmission, Emergency Department (ED)/urgent care visit, or death |
| Number of moderate or severe COPD exacerbations | Through day 90 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to first COPD-related event | Through day 90 | COPD-related event may include non-elective hospital readmission, Emergency Department (ED)/urgent care visit, or death |
| Time to first moderate and/or severe COPD exacerbation | Through day 90 | — |
| Number of all-cause non-elective hospital readmissions | Through day 90 | — |
| Number of ED visits | Through day 90 | — |
| Number of COPD-related hospital readmissions | Through day 90 | — |
| Number of COPD-related ED visits | Through day 90 | — |
| Number of all-cause deaths | Through day 90 | — |
| Number of COPD-related deaths | Through day 90 | — |
| Occurrence of all-cause non-elective hospital readmissions | Through day 60 | — |
| Occurrence of all-cause ED visits | Through day 60 | — |
| Occurrence of all-cause deaths | Through day 60 | — |
| Occurrence of COPD-related hospital readmissions | Through day 60 | — |
| Occurrence of ED visits | Through day 60 | — |
| Occurrence of deaths | Through day 60 | — |
| Change in Chronic Airways Assessment Test (CAAT) score | From baseline through day 90 | CAAT is a PRO measure that assesses the impact of lung disease on a person's life using an 8-item questionnaire with a 40-point scale with higher scores indicating worse disease. |
| Change in EXAcerbation of Chronic pulmonary disease Tool (EXACT) questionnaire score | From baseline through day 90 | EXACT is a patient-reported daily diary that captures respiratory symptoms in COPD using a 14-item questionnaire with a 0 to 100-point scale with higher scores indicating worse disease symptoms. |
| Occurrence of Treatment-Emergent Adverse Events (TEAEs) | Through day 90 | — |
| Occurrence of Serious Adverse Events (SAEs) | Through day 90 | — |
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed